Kornimate/medical-research-clean huggingface dataset:
dose dense chemotherapy with lipegfilgrastim support in early breast cancer

Conditions: Breast Cancer

Summary: this is a prospective, non-interventional, single arm study, which is examining doxorubicin and cyclophosphamide (ac) once every 2 weeks with lipegfilgrastim support in early breast cancer.

an important advance in the use of dose dense chemotherapy regimens for breast cancer was the development of pegylated form of g-csf (pegfilgrastim and lipegfilgrastim), which offered the convenience of single subcutaneous injection, rather than multiple daily injections lipegfilgrastim is a pegylated long-acting covalent conjugate of filgrastim (g-csf). in a pivotal randomized phase iii study in breast cancer lipegfilgrastim was shown to be non-inferior to pegfilgrastim. in this prospective observational study the incidence of treatment-related neutropenia following four cycles of dose dense (every 2 week) doxorubicin cyclophosphamide (ac) with lipegfilgrastim support is being investigated. data will be collected on 40 consecutive patients treated with ac and lipegfilgrastim in ireland. the primary objective of this study is to determine the incidence of treatment-related neutropenia following four cycles of dose dense doxorubicin cyclophosphamide (ac) with lipegfilgrastim support (8 weeks). secondary objectives 1. determine the incidence of febrile neutropenia during 4 cycles (8 weeks)of dose dense ac with lipegfilgrastim 2. examine the incidence of treatment-related neutropenia during subsequent intravenous cancer therapy up to 1 year.

Eligibility criteria:
inclusion criteria: 1. age ≥ 18 years 2. stage i-iii breast cancer 3. eastern cooperative oncology group (ecog) performance status 0-1(see below) 4. adequate bone marrow function as defined by neutrophil count of ≥1.0 and platelet count of ≥ 100 5. planned chemotherapy with dose dense doxorubicin-cyclophosphamide (ac) as deemed appropriate by a consultant medical oncologist general indications for dose dense ac include: 1. t3 or t4 tumours 2. n1 - n3 (node positive) disease 3. human epidermal growth factor receptor 2 (her2) positive tumours. 4. triple negative breast cancer as evidenced by lack of expression of the estrogen receptor (er), progesterone receptor (pr) and her2 exclusion criteria: 1. stage iv breast cancer 2. pregnancy 3. previous chemotherapy exposure 4. prior exposure to g-csf 5. known positive hiv status 6. cardiac or other concurrent illness, which at the investigator's discretion contraindicates the use of ac

Keywords: early
nonvisual foot inspection for people with visual impairment

Conditions: Diabetes; Visual Impairment

Summary: the purpose of this study was to find out whether a method of nonvisual foot inspection, using the senses of touch and smell, helps people with diabetes and visual impairment to find new foot problems when they are in early, easily-treated stages. all people in the study had regular foot inspections by podiatrists. the results include how people feel about the method, whether they actually did check their feet it, and whether the method helped them to discover foot problems themselves.

data gathered over the course of 1 year: * bimonthly phone calls to ask about foot care practices at home over the last week * a baseline comprehensive foot evaluation and 4 additional comprehensive evaluations every 3 months qualitative data: - focus groups immediately after comprehensive diabetes self-management education, and 1 year later, to determine acceptability of foot care procedures and patient perceptions about effectiveness

Eligibility criteria:
inclusion criteria: * over age 18 * diagnosed with diabetes (either type 1 or type 2) * having visual impairment exclusion criteria: * self-reported numbness in hands * inability to pass a brief screening for decisional capacity

Keywords: diabetes visual impairment blindness foot care self-management
discontinuation of tobacco dependence in smoking patients with squamous cell carcinoma of the head-neck district: multicenter prospective observational study

Conditions: Cancer of Head and Neck

Summary: the primary objective of our study is to evaluate the effectiveness of a standardized clinical practice counseling strategy for promoting post-diagnosis smoking cessation among patients with scchn. efficacy will be measured as the percentage of patients who succeed in sustained smoking cessation ("sustained quitters," see below) at 6+1 months after enrollment, i.e., after the initiation of anti-smoking counseling.


Eligibility criteria:
inclusion criteria. * patients with scchn tumors of the oral cavity, oropharynx, hypopharynx, larynx, nasopharynx, and paranasal sinuses. * patients older than 18 years of age with scchn of these sites who are candidates for surgical/radiotherapy (rt)/radiochemotherapy (rtct) treatment with curative intent (primary treatment). * patients with scchn who are active smokers, or have quit smoking for less than 30 days, at the time of initiation of the process (visits and instrumental tests) that led to the diagnosis of cancer exclusion criteria * patients with scchn cancer who have quit smoking for more than 30 days at the time of initiation of the diagnostic process. * patients using only e-cigarettes at the time of initiation of the treatment process. * patients with non-scchn cancer in recurrent metastatic stage and not eligible for curative purpose therapy.

Keywords: cancer head&amp;neck smoker
paclitaxel plus estramustine in treating patients with metastatic prostate cancer

Conditions: Prostate Cancer

Summary: rationale: drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. combining more than once drug may kill more tumor cells. purpose: phase ii trial to study the effectiveness of paclitaxel plus estramustine in treating patients who have metastatic prostate cancer that has not responded to hormone therapy.

objectives: i. determine the response rate (psa and/or objective response) and duration of response to weekly paclitaxel plus estramustine in patients with metastatic hormone refractory prostate cancer. ii. determine the effect on quality of life of this regimen in these patients. outline: patients receive paclitaxel iv over 1 hour weekly for 4 weeks. patients receive oral estramustine the day before, the day of, and the day after paclitaxel administration each week. courses repeat every 4 weeks in the absence of unacceptable toxicity and disease progression. a quality of life questionnaire is completed before treatment and 2 months after treatment initiation. projected accrual: a total of 17 patients will be accrued for this study.

Eligibility criteria:
disease characteristics: histologically proven metastatic (d1 or d2) hormone refractory adenocarcinoma of the prostate with one of the following: -bidimensionally measurable disease -bone only metastases with rising psa levels -psa only disease defined as rising psa levels with prior confirmation of d1 or d2 disease psa must be greater than 8 if bone only or psa only disease hormone failure defined as progression after treatment with orchiectomy, lhrh agonist, des alone, or any hormonal treatment in combination with antiandrogen therapy patient characteristics: age: not specified performance status: zubrod 0-2 life expectancy: not specified hematopoietic: absolute granulocyte count at least 1,500/mm3 platelet count at least 100,000/mm3 hepatic: bilirubin no greater than 1.5 times upper limit of normal (uln) sgot no greater than 2 times uln renal: creatinine no greater than 2.0 mg/dl other: no other active malignancies within the past 5 years except nonmelanomatous skin cancer or other in situ cancer prior concurrent therapy: biologic therapy: not specified chemotherapy: at least 4 weeks since prior chemotherapy no prior estramustine alone or in combination with other chemotherapy no prior taxanes no more than 1 prior chemotherapy regimen endocrine therapy: concurrent primary hormonal therapy allowed (lhrh agonist or orchiectomy) at least 4 weeks since prior antiandrogen therapy with at least 2 rises in psa levels radiotherapy: at least 4 weeks since prior radiotherapy at least 8 weeks since prior strontium-89 therapy surgery: see disease characteristics

Keywords: adenocarcinoma of the prostate stage iv prostate cancer recurrent prostate cancer
pilot bleeding study: risk and protective factors associated with bleeding in the hemodialysis population

Conditions: Bleeding; End Stage Renal Disease

Summary: this study is examining the risk and protective factors associated with bleeding in the hemodialysis population.


Eligibility criteria:
inclusion criteria: * patient is undergoing hemodialysis exclusion criteria: * this is an observational study. no exclusion criteria required.

Keywords: bleeding end stage renal disease antiplatelet therapy anticoagulant therapy hemodialysis
il17 in systemic lupus erythematosus patients: association with disease activity and organ damage

Conditions: Systemic Lupus Erythematosus

Summary: many laboratory markers can be measured for assessment of lupus activity as aberrant manufacturing and imbalance of the cytokines of t-helper cell which already have been implicated within autoimmunity pathogenesis as il-18 and il-10 levels are usually elevated in lupus sufferers and correlated with sledai score il-17 has been linked to immune-mediated organ damage in several autoimmune diseases and recently it has been linked to pathogenesis of a murine model of lupus and human lupus diverse cytokine abnormalities which common in lupus patients may skew t cells differentiation into il-17-producing cd4+ and double negative t cells. this could promote the autoimmune process by activation of immune cells \&stimulation of proliferation of b-cell and production of antibody


Eligibility criteria:
inclusion criteria: * sle will be diagnosed according to the 2012 systemic lupus international collaborating clinics (slicc) classification criteria for sle * age ≥ 18 years. * patients who are able and willing to give written informed consent exclusion criteria: -any other autoimmune disease rather than sle. - * systemic diseases * malignancy * pregnancy
novel biomarkers of thrombotic risk

Conditions: Myocardial Infarction

Summary: treatment of patients who have had a heart attack with drugs that prevent formation of blood clots has been shown to reduce the patient's risk of subsequent cardiovascular events such as heart attack, stroke, and death. because new drugs have increased treatment options, the development of tests that can guide treatment should improve treatment selection and further reduce the risk of cardiovascular events as well as bleeding. this study is designed to assess the value of new tests. it is a prospective study that will enroll patients who have had a heart attack. blood will be taken during hospitalization for a heart attack (1 day after their heart attack) and a second time 6 months later during an ambulatory clinical visit. investigators will perform biochemical tests on the blood that assess the likelihood of making blood clots. one tablespoon of blood will be taken at each time. taking this amount of blood poses no risk to the participant. investigators will ask the participant whether they have had bleeding or cardiovascular events during the initial evaluation, the ambulatory follow-up at 6 months, and during a telephone interview 1 year after enrollment. during their 1 year of participation, investigators will review medical records and record information in a manner that protects the identity of all participants. we hypothesize that the biochemical test results will be similar at baseline and 6 month follow-up and that these biochemical tests will identify patients at greater risk of cardiovascular events and bleeding. treatment of participants will not be altered by their participation in this study.


Eligibility criteria:
inclusion criteria: * myocardial infarction demonstrated by elevated markers of cardiac injury (troponin i (tni) or creatine kinase (ck) mb fraction) * the presence of coronary artery disease demonstrated by cardiac catheterization or perfusion imaging exclusion criteria: * treatment with long term anticoagulants * active infection * malignancy

Keywords: platelet reactivity, thrombin generation
meditation to reduce stress and improve quality of life

Conditions: Stress

Summary: the purpose of this study is to test a simple meditation program that is easy to learn; inexpensive; easy to practice; non-religion based; and has wide applicability to multiple medical conditions. this program has been developed by the complementary and integrative medicine program at the mayo clinic.

stress is a ubiquitous problem and a mediator of symptoms for a variety of medical conditions. most medical diagnoses, procedures, and physician visits are associated with considerable stress. excessive stress is associated with adverse medical outcomes, unhealthy coping mechanisms, symptoms of anxiety and depression, and overall a poor quality of life. no specific pharmacologic treatment is available for treating stress. further, it is often difficult or impossible to change the reality of circumstances causing stress in an individual. thus increasing individual coping mechanisms and ability of a person to handle stress, rather than changing the stressors itself, might be a more feasible approach towards reducing stress. meditation is a widely used and increasingly popular intervention that positively affects the individual at cognitive, physical, emotional, behavioral, and spiritual levels. a practice of meditation has been shown to reduce symptoms of stress and improve overall quality of life. several meditation programs exist, however most are limited by considerable expense, need for elaborate training, lack of widespread availability, or incorporation of ideas and practices unique to a particular culture.

Eligibility criteria:
inclusion criteria: * at least 18 years of age * good general health * access to a dvd player * provided with, understand, and have signed the informed consent exclusion criteria: * are currently using (at the time of enrollment) antipsychotics or recently (\< 3 months) started on antidepressants. patients on stable dose of antidepressant (for ≥ 3 months) will be allowed. * have a lifetime history of schizophrenia

Keywords: meditation relaxation therapy quality of life
advance care planning in palliative care

Conditions: Palliative Care

Summary: the question of the end of life is a major public health issue. in the field of palliative care, the notion of anticipation is central for people with a serious and progressive illness. indeed, an important consideration for general practitioners is the need to anticipate the disease's evolution and the uncomfortable symptoms (physical or psychological) the patient is likely to experience. this approach aims to relieve the patient without delay and thus improve comfort to ensure an acceptable quality of life for patients and their families. even if the usefulness of anticipatory prescribing seems obvious, their use is not generalized to all palliative care patients. caregivers are confronted with obstacles to the implementation of these prescriptions, particularly with regard to the relationship with the patient. it can then be assumed that patients' experiences and perceptions may influence symptom management and the use of anticipatory prescriptions. it seems essential to explore this subject. for this purpose, the investigator will carry out a qualitative study based on individual semi-structured interviews with palliative care patients.


Eligibility criteria:
inclusion criteria: * persons of all genders * persons 18 years of age and older * in a palliative care situation of any serious illness * persons hospitalized in palliative care unit at the givors hospital or followed at home by the mobile palliative care team * patients who have received full information about the study and signed a written consent. exclusion criteria: * persons under legal protection * persons unable to express their consent, making it impossible to conduct interviews: dysarthria, cognitive disorders, mental confusion, altered state of consciousness * pregnant or breastfeeding persons

Keywords: palliative care advance care planning anticipatory prescribing end of life patient experiences
pk and safety study of biib074 in healthy japanese and caucasian participants

Conditions: Healthy; Trigeminal Neuralgia

Summary: the primary objectives of this study are: to evaluate pharmacokinetics (pk) properties of biib074 administered as a single oral dose in healthy japanese and caucasian participants; and to evaluate the pk properties of biib074 administered as repeated oral doses in healthy japanese participants. the secondary objective of this study is to assess the safety and tolerability of biib074 administered as a single oral dose (japanese and caucasian participants) and as repeated oral doses (japanese participants).


Eligibility criteria:
key inclusion criteria: * japanese or caucasian. * japanese participants must have been born in japan, and their biological parents and grandparents must all have been of japanese origin. * must have a body mass index between 18 and 30 kg/m2, inclusive. key exclusion criteria: * previous exposure to biib074, with the exception that japanese participants who complete part 1. * use of any oral, injected, or implanted hormonal method of contraception that contains ethinyl estradiol within 28 days of day -1 and an unwillingness to refrain from product use during study participation. note: other protocol defined inclusion/exclusion criteria may apply.
the evaluation of surgical decisions and prognosis of the radiomics and watson artificial intelligence in patients with hepatocellular carcinoma

Conditions: Liver Resection

Summary: the aim of this study was to evaluate the surgical decisions and prognosis of the radiomics and watson artificial intelligence in patients with hepatocellular carcinoma.

hepatectomy is an effective treatment for patients with hepatocellular carcinoma, but liver failure after hepatectomy may lead to increased postoperative mortality.therefore, it is very important to make preoperative surgical decisions, evaluate the safety of the operation and identify which patients are likely to suffer from liver failure.imaging omics is a newly emerging research method in recent years, which has great potential in cancer diagnosis and treatment, and can monitor treatment and predict the prognosis of patients, so as to better realize accurate diagnosis and treatment of diseases.the artificial intelligence platform developed by ibm watson for watson tumor treatment decisions can provide treatment decisions and corresponding theoretical basis to guide surgical decisions based on the key clinical data of liver cancer patients.

Eligibility criteria:
inclusion criteria: 1. 18 years≤ age ≤80 years 2. compling with the diagnosis criteria of complex hepatic carcinoma. 3. primary hepatic carcinoma without intrahepatic or extrahepatic extensive cancer metastasis, the metastatic hepatic carcinoma whose primary focal has been controlled 4. preoperative liver function is child - pugh grade a or b. 5. the patients are volunteered for the study. exclusion criteria: 1. patients with mental illness. 2. patients can't tolerate the operation owe to a variety of basic diseases (such as severe cardiopulmonary insufficiency, renal insufficiency, cachexia and blood system diseases, etc.) 3. the patients refused to take part in the study. 4. there are other co-existed malignant tumors. 5. benign liver diseases. 6. indocyanine green allergy

Keywords: radiomics watson artificial intelligence hepatocellular carcinoma surgical decisions prognosis
study to evaluate the safety and tolerability of weekly intravenous (iv) doses of bms-906024 in subjects with acute t-cell lymphoblastic leukemia or t-cell lymphoblastic lymphoma

Conditions: Lymphoblastic Leukemia, Acute T-cell; Precursor T-Cell Lymphoblastic Lymphoma

Summary: the purpose of this study is to identify a safe and tolerable dose of bms-906024, either alone or in combination with dexamethasone in subjects with t-cell acute lymphoblastic leukemia or t-cell lymphoblastic lymphoma who no longer respond to or have relapsed from standard therapies

minimum age: 10 years and older at selected sites

Eligibility criteria:
for more information regarding bms clinical trial participation, please visit www.bmsstudyconnect.com. inclusion criteria: * subjects with t-cell acute lymphoblastic leukemia or t-cell lymphoblastic lymphoma refractory to or relapsed from standard therapies * life expectancy of at least 2 months * performance status (ps) 0-1 (a measure of the ability to carry out activities of daily living); subjects with ps 2 are eligible if due to disease related symptoms * prior anti-cancer treatment permitted (with specific criteria) * adequate organ function exclusion criteria: * infection * elevated triglycerides * gastro-intestinal disease with increased risk of diarrhea (e.g. inflammatory bowel disease) * unable to tolerate bone marrow biopsy * taking medications known to increase risk of torsades de pointes (an abnormal heart rhythm)
adapted physical activity, health-related quality of life and satisfaction with care in hospitalized children

Conditions: Hospitalization

Summary: the aim of this study is to assess the efficacy of adapted physical activity intervention on health-related quality of life and satisfaction with care in hospitalized children and adolescents. this is a randomized controlled study. the hypothesis is that children practicing adapted physical activity during their hospitalization present a higher health-related quality of life and satisfaction with care than those who do not.


Eligibility criteria:
inclusion criteria: * length of hospital stay (more than 3 days) * children or parents able to understand and read french * no medical contra-indications to physical activity * children hospitalized in 3 specific departments at nancy children's hospital: * médecine infantile 1 et 3(paediatrics) * médecine infantile 2 (haematology-oncology, immunology department) * chirurgie orthopédique et brûlés (orthopaedic surgery and burned) * children and parents being agree to participate in the study exclusion criteria: * no written informed consent * children hospitalized less than 3 days * medical contra-indication to physical activity * children already included in that study (former hospitalization)

Keywords: adapted physical activity hospital health-related quality of life satisfaction with care child adolescent randomized controlled trial physical activity quality of life